EN-60601-1

PI200

Information in this document is subject to change without

notice. No part of this document may be reproduced or
transmitted in any form or by any means, electronic or
manual, for any process without the prior permission of
TERUMO PENPOL Limited. TERUMO PENPOL Limited may
have patents or pending patent applications, trademarks or
other intellectual property rights covering subject matter in
this document. The furnishing of this document does not
give you license to these patents, trademarks except as
expressly provided in any written license agreement from
TERUMO PENPOL Limited.

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IMPORTANT
This user manual is written for the person responsible for
the operation of Platelet Incubator PI200. The operational
method and routines are drawn to ensure reliable, safe and
effective operation of PI200. It is important that the operator
has studied and understood the contents of this manual
before using Platelet Incubator PI200.

WARRANTY
1. The warranty includes equipment or a component
that proves to have faults during the warranty
period. In such case, Terumo Penpol Limited will,
without cost to the customer, repair or replace
the components or equipment.

2. The warranty is not valid if the equipment has

been repaired by anyone else other than qualified
personnel that are approved by Terumo Penpol
Limited / Branch Office.

3. The warranty is not valid if the equipment has

been changed in any way that, according to
Terumo Penpol Limited’s opinion, affects the
reliability and stability of the product.

4. The warranty is not valid, if the equipment has

been used in any other way than that described
in the operating procedure.

5. The warranty is not valid when the serial number

has been changed, crossed over or been removed
or if the fault has been caused by misuse or
abnormal use.

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Contents
1. INTRODUCTION ....................................................... 5

2. Reference Regarding Platelet Storage......... ........... 5

3. Features of PI200.......................................... ........ 6

4. Installation Details…...................................... ....... 7

5. Specifications.................................. ...................... 10

6. Construction.................................................. ...... 12

7. Temperature Recorder and Control Unit....... ......... 12

8. Interpreting Alarms........................................ ....... 13

9. Operating Instructions................................... ....... 15

10. Theory of Operation...………………………... .......... 18

11. Trouble Shooting........................................... ....... 20

12. Cleaning........................................................ ....... 22

13. Contact Address............................................ ....... 23

14. Warranty Card

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1. INTRODUCTION
The Platelet Incubator PI200 is designed to store platelet
concentrates in controlled temperatures. Platelet Incubator
PI200 with Platelet Agitator PA300 increases platelet viability,
post transfusion recovery and preservation of platelet
morphology.

The Platelet Incubator PI200 is designed to conform to

the standards laid down by AABB and WHO guidelines.
The basic refrigeration cycle consists of a hermitically sealed
compressor, Condenser, Evaporator and a Capillary. Forced
air circulation is present inside the incubator to maintain
the temperature gradient within ±1.0ºC. In places where
the ambient is liable to be less than 18°C, a sealed heater
is also provided.

2. REFERENCE REGARDING
PLATELET STORAGE
Platelets shall be placed in storage not exceeding for a period of 5 days,
between 20 degree centigrade to 24 degree centigrade, with continuous
gentle agitation of the platelet concentrates maintained throughout such
storage.
Drugs & Cosmetics Act and Rules

Platelet concentrates, which are stored in Blood Bank for up to 5 days at

20~24°C with constant gentle agitation have nearly normal post
transfusion recovery and survival.
Blood transfusion Therapy, AABB

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3. FEATURES OF PI200
„ Forced air circulation is present inside the
incubator to maintain the temperature gradient
within±1.0°C. In places where the ambient is liable
to be less than 18°C, a sealed heater is also
provided.

„ The Platelet Incubator PI200 is equipped with a

built in Temperature Recorder and Controller Unit
(records on a circular chart), which has a digital
temperature sensor for temperature sensing. This
does not require manual calibration.

„ CF lamp provides uniform lighting.

„ To accommodate the fluctuations in the input

power condition a built in stabiliser is provided.

„ Alarms provided for (a) Compressor ON, (b) Heater

ON, (c) Temperature High, (d) Temperature Low
(e) Door Open, (f) Agitator OFF, (g) System OK,
(h) Battery Low, (i) Sensor Failure, (j) Power Failure.

„ Electronically controlled sealed heating element

„ Transparent door

„ CFC Free refrigerant

„ Auto stop for agitation when the door is opened

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„ Unique air circulation system maintains incubator

chamber uniformly at FDA recommended
temperature ranges of 22±2°C.

„ 2 hour battery backup for Temperature

Indications

4. INSTALLATION DETAILS
Unpacking
„ Inspect the packing for shipping damages. If you
find any, notify Terumo Penpol Limited / Branch
Office.

„ The items received may be cross verified against

the P.O and packing slip, any missing or damaged
items must be reported immediately to the carrier
and Terumo Penpol Limited / Branch Office.

Packing Details
The package contains the following items

„ Platelet Incubator 1 No
„ CF Lamp 1 No
„ Chart 50 Nos
„ Chart Holding Magnet 1 No
„ Pen 5 Nos
„ Sensor Bottle 1 No
„ Key 2 Nos

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„ User Manual 1 No

„ Packing List 1 No

„ Test Certificate 1 No

„ Power cord 1 No

„ Do’s & Dont’s 1 No

Installation Procedure
„ Ensure proper earthing of power point

„ Ensure that the Serial No. in the warranty card in the

user manual and Serial No. on the equipment are
same

„ Ensure that the input voltage to the unit is as per

the voltage specified.

„ Carefully remove the packing material without

damaging parts of the equipment. The Platelet
Incubator PI200 will be packed with PE sheets. Open
the top of the box and take out the corrugated
packing from the corners. Clean the equipment well.

„ Place the PI200 on a level surface.

„ Place the sensor bottle in the bottle clamp and CF

lamp in the light holder.

„ Fill the bottle provided with the correct composition

i.e., 0.25% of glycerin in water and keep the sensor
dipped in this.

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„ Place a new chart in the TRCU and place the chart

holding magnet on the chart holder.

„ Insert the pen into the needle.

„ Plug the unit and switch ON

„ Switch ON the battery switch in the front panel of

TRCU

„ The Platelet Incubator PI200 is now ready for use.

Precautions for Installation and Use

„ The unit is shipped in a complete condition. Generally
no adjustments are required to be done to any of
the components of this unit.

„ Install incubator away from heating appliances.

„ Install Incubator away from the wall by about 30

cm, which provides good ventilation for the
condenser.

„ Provide separate plug/socket for the incubator.

„ Good air circulation is necessary inside the cabinet

for keeping all the bags at the desired temperature.
Hence place all bags neatly and do not overload
beyond its maximum capacity.

„ Keep door opening time at minimum.

„ Place the Platelet Agitator at the center of the

equipment. Ensure proper inter-connection
between Platelet Agitator and Incubator.

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5. SPECIFICATIONS
Product code PI200

Input Voltage 230±10%VAC

50Hz Single Phase

Fuse 250V, 6.3A, 5 x 20 mm

type M, Catridge

Power 400W(Max)

Capacity 120Litres

Cabinet Material

External 20 swg GI sheet, powder coated/22swg

SS sheet

Internal 24 swg SS sheet

Dimensions (ext) 960 X 705 X 565 mm

Dimensions (int) 560 X 610 X 460 mm

Display 4x7segment LED (Red)

Display Resolution 0.5°C

Accuracy of recorder ±1 °C

Accuracy of the digital

sensor ± 0.5 °C

-Recording is made on a
weekly chart paper using
ink type pen.

Recording -Or recording is made on

pressure sensitive weekly
chart paper using pointed
metal pen (this feature is
optional).

Chart range 0-40°C

Chamber
temperature Range 22 ± 2°C

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Lamp 14W CFL

Battery Backup for TRCU 2hr battery backup is

provided with 12V, 2.3 Ah
Rechargeable Sealed
Maintenance free Lead Acid
Battery

Audio And Visual Alarms. Audio and visual alarms

Audio alarm is a are provided for
piezoelectric buzzer. z High Temperature
External alarm provision z Low Temperature
is also present. z Agitator OFF
z Sensor failure
z Door Open

Visual Indications z Power Failure

z Power ON
z Line In
z System OK
z Compressor ON
z Heater ON
z Low Battery

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6. CONSTRUCTION
The cabinet is of a single body structure with rust – proof
stainless steel interior and powder coated exterior. The
stainless steel interior aids in temperature stability and
simplifies cleaning. Adequate insulation is provided by using
high-density formed polyurethane, which ensures steady
temperature maintenance and keeps the heat losses to a
minimum.

Inbuilt Condensate Evaporator:

No more dangling tubes to remove the condensed water.
The Incubator contains an in-built Condensate Evaporator,
which converts the collected condensate into vapour utilising
the heat of the system itself.

7. TEMPERATURE RECORDER AND

CONTROL UNIT
TRCU (Temperature Recorder and Control unit) performs the
dual functions of Recording the temperature on the circular
chart and controlling the temperature of the Platelet
Incubator.
Features:
„ The TRCU has a digital temperature sensor for
temperature sensing. This does not require
manual calibration.

„ Chart change and chart set buttons for changing

the chart without damaging the pen holder. This
allows the user to change the start time settings
for recording on chart. This also prevents damage
to the needle driving stepper motor.

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„ “Alarm acknowledge” switch for turn off power

failure alarm as well as other common alarm
conditions.

„ Visual indications : The following LED indications

are available on the TRCU panel

„ Compressor ON
„ Heater ON
„ Temperature high
„ Temperature Low
„ Door Open
„ Agitator OFF
„ System O. K.
„ Battery Low

„ “b” indication on the left side of the 7 segment

display when working in battery.

8. INTERPRETING ALARMS
The audio alarm has to be viewed in conjunction with the
visual indications. The following visual indications are also
available.

Power: Indicates that the power to the internal voltage stabiliser

is OK

Line In: Indicates that the power to the entire system from
the voltage stabiliser is OK

Compressor On: If the “compressor ON” indication is glowing

it shows that the compressor has been switched ON to bring
down the temperature so that it remains within the specified
range.

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Heater ON: If this LED is glowing it shows that the heater

has been switched ON to increase the temperature so that it
remains in the range.

Temperature High: This indication shows that the

temperature is above the acceptable range. Audible alarm is
also present.

Temperature Low: This indication shows that the

temperature has gone below the acceptable range. Audible
alarm is also present.

Agitator OFF: The TRCU detects whether the agitator is

working or not. The indication when glowing shows that
the agitator is not working. Audible alarm is also present.

Door Open: The visual indication shows that the door has
been left open. An audible alarm comes on if the door is left
open for more than one minutes.

System Ok: This LED indicates that the sensor is working

properly.

Note: If the sensor is removed this indication goes OFF and

an error signal (- E2 -) comes on in the display, indicating
that something is wrong with the sensor. If the sensor is
then replaced back the indication may come back indicating
sensor OK. But the system has to be reset if the sensor has
to work properly.

Battery Low: This indication shows that the battery charge

is low.

When power fails a “b” will blink in the left side of the 7
segment display.

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9. OPERATING INSTRUCTIONS
„ Switch the equipment ON.
„ Monitor the circular chart and temperature
display and make sure that both are indicating
the same value.

TRCU Initialisation Cycle

The initialisation cycle is a very important diagnostic tool.
The following actions will be performed by the TRCU in order.

1. All the relays will be switched OFF.

2. The LED’s will turn ON and then turn OFF
3. The display will be initialised to ‘0000’
4. The needle will move to the left, detect the opto
sensor and stop. If the needle does not stop then
the opto sensor is defective. The needle will then
climb on to the needle rest.
5. The LED’s will again turn ON and Turn OFF
indicating that the initialisation routine is now
over.
6. The actual temperature will be displayed and the
needle will move to the corresponding mark on
the chart.
7. Appropriate LED’s and alarm will turn ON.
8. During power failure “b” will blink on the 7-
segment display.

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To replace the pen on the needle

(in the case of ink pen)
Switch OFF the TRCU.

A and B has to coincide for propoer marking.

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Changing the Chart

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Battery Backup

10. THEORY OF OPERATION

Functional Block Diagram

Functional description

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„ Heater: Heater will keep the temperature inside

the incubator within limits even if the low ambient
temperature.

„ Temperature Recorder & Control Unit: It con-

trols the “switching ON” and “switching OFF” of
the compressor. The TRCU has a digital sensor which
senses the temperature inside the the refrigerated
space.

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Based on this input the TRCU controls and Records the

temperature inside the incubator. The recording is done
on a seven day chart using a pen.

11. TROUBLE SHOOTING

Problem Observed Possible Remedy

The Platelet Incubator „ Verify outlet is good or Plug
does not work. into a different outlet
„ Check the input power; it
must be as per specified
voltage
„ Check proper cord
connection, or else replace
the power cord
„ Check if the fuse of the TRCU
is blown. Replace if required.

Unit hums and „ Low voltage to the unit;

shuts OFF determine the reason and
correct.
„ Inoperative relay. Call
service engineer

System resets when „ Call service engineer

the door is opened.
Unit runs excessively „ Frequent door opening. Do
not open door frequently and
keep the time for which the
door is open at minimum.
„ Poor door seal.
„ Insufficient air circulation
over condenser or condenser
is not clean. Insufficient gap
between wall and the
incubator.

High noise level „ Give proper base support to

the equipment

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„ Place the incubator on a level

surface or provide some
packing at the required
position
Unit cools but does „ Internal fan not working.
not get to set point. Press the door switch and
see whether internal fan is
working. If not adjust the
door switch for the
internal fan.
High rate of climb of „ The sensor is not dipped
temperature on in the glycerine solution
opening the door or the level of glycerine is
not sufficient. Position the
sensor or fill the bottle to the
required level
Temperature inside „ Compressor not working.
the cabinet going „ TRCU not working.
out of acceptable „ Call service engineer.
levels
The temperature „ The sensor is not connected
indication shows properly or the Sensor is
- E2- and alarm faulty.
Sounds
The chart is not „ The unit may have been left
being recorded in the chart change mode. A
“c” in small case will be
indicated on the left side of
the temperature indication.
Press chart change once to
move it out of this mode
„ The chart moving motor is
not working. To confirm
press chart change. The
needle goes to one corner.
Then press alarm
acknowledge/ chart set to
see the chart moving
„ Pen dried out
„ Pen arm bent - Or else -
„ Call service engineer

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" For all other problems call the service engineer or your
local TERUMO PENPOL Limited office. Do not attempt
to open the unit. Warranty will not be valid if the
unit is opened.

12. CLEANING
„ To clean the unit use a clean dry cloth. Do not
clean with wet cloth, cloth dipped in ether, or
other organic solvents.

„ The finned condenser can become clogged with

dust. The openings between the fins should be
kept clean. A vacuum cleaner may be used for
this purpose. Failure to keep the condenser fins
free of dirt will result in erratic operation and
may damage the system.

„ Clean the unit frequently so that dust does not

accumulate.

„ Do not open the unit or try to clean the internal

parts.

„ No parts of the equipment can be lubricated by

the user. Do not attempt to open the Equipment
and apply lubricants.

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13. CONTACT ADDRESS

For complaints / suggestions please contact your nearest authorized

service personnel or contact nearest Terumo Branch:

TERUMO PENPOL Limited

Medical Systems Group

TC 27/373, Andoor Buildings,
General Hosp. Road, Trivandrum
Kerala, India - 695 035.
Corporate Office:
I - 2, Jawahar Nagar
Trivandrum-695003, Kerala, India.
Tel: 91- 471-3015500 / 3015501.
Fax: 91- 471-2721519

Tel: +91-471-3015800.

Fax: +91-471-3015805

Email: service@terumopenpol.com

In the event you require further technical clarifications / help, do

contact us at info@terumopenpol.com. Our technical experts will

be able to provide you with the required support. Do let us have your

feedback regarding the Equipment. Continuing with our Vision of

“Better Ways to Better Health Care” your feedback will help us

in serving you better.

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ZONAL OFFICES IN INDIA

Chennai : Tele : +91-44 - 42054528 / 42054538

Fax : +91-44 - 42054528

Ahmedabad: Tele : +91-79 - 26580369 / 26580370

Fax : +91-79 - 26580370

Kolkata : Tele : +91-33 - 25344609

Fax : +91-33 - 25344623

Mumbai : Tele : +91-22 - 28938683 / 28949944

Fax : +91-22 - 28949944

Bangalore : Tele : +91-80 - 26618858

Fax : +91-80 - 26522265

Delhi : Tele : +91-11 - 25741637 / 42437170

Fax : +91-11 - 25748298

Visit www.terumo.co.jp for TERUMO worldwide offices. UM/PI200/MAR2011/Rev 7

* Due to continuous development, specifications

are likely to change without prior notice.

This product is manufactured by Terumo Penpol Limited.

® Registered Trademark.

© TERUMO PENPOL Limited. December 2009. Printed in India.

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WARRANTY
Dear Customer,

Please accept our hearty congratulations on choosing TERUMO

PENPOL equipment. We are sure that this marks the beginning of a
long and mutually satisfying relationship.

Details of the warranty period and terms of validity are outlined in

this document. We would request you to go through the same.

Apart from covering your installation through the warranty with

which your equipment comes, we have post warranty service options
available. Your nearest Terumo Branch / Distributor will be happy to
give you the details. It is advisable to get in touch before the warranty
expires. This will enable us to work out an option that suits you best.
Once again we thank you for placing your trust in TERUMO PENPOL
Limited.

Best Regards,

Authorised Signatory
Medical Systems Group
TERUMO PENPOL Limited

TERMS OF WARRANTY
The warranty covers repairing/replacement of any defective
hardware items from the configuration listed in the Warranty
Card, contingent to these defect having arisen only out of
faulty design or workmanship if brought to the notice of
TERUMO PENPOL Limited, in writing, on or before the date at
expiry of warranty mentioned on the Warranty Card. Warranty
is valid for a period of two year from the date of installation or
27 months from the date of delivery (excludes compressor for
which one year is applicable) specifically agreed in writing by
TERUMO Branch officials.

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Warranty Number Date:

Customer Code :

Customer Name :

Installation Address :

PI200
Date of despatch :
Date of Installation :
DC No. Description Eqpt. Sl.No.

TERUMO PENPOL Limited, undertake to repair/replace any defective items from

the products listed above subect to the conditions mentioned overleaf.

Installation Remarks :

TERUMO PENPOL LImited, Medical Systems Group

TC 27/373, Andoor Buildings, General Hospital Road, Trivandrum, India
Registered Office : I-2, Jawahar Nagar, Trivandrum 695 003

PI200