Attachment F - Label Version 2

Attachment F - Label Version 2.pdf

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Attachment F - Label Version 2

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ATTENTION: These instructions do not include all the information needed for the safe and effective use
of this pump. See the full Device Labeling for more complete information on the use of this device.
Brand Name

Tohamadi Large Volume Infusion Pump

Manufacturer

Ivy Test Systems

Model

TOW724

Display
Screen

Charger

Battery
Charge
Indicator
Numeric
Keypad

1

2

4

3

5

7

6

8

E

9

0

C

START Button
1

2

3

ALARM Button

Door
Latch

4

5

6

PAUSE Button

7

8

9

Infusion
Catheter
Line In

E

0

C

UP/DOWN Buttons
STOP Button
CLEAR Button
ENTER Button

AC Adapter

Description	

This is a single channel large volume infusion pump with a flow
sensor and alarms for occlusions, air inEnter
line, and low battery. There
is no lockout mechanism on this pump. The Tohamadi TOW724 can
Clear
be mounted on a pole. 1 2 3

Uses 	
Enter

1

2

4

3

5

7

8

Clear

6
9

0

4
5
6
This pump is recommended
for infusions
that require large volumes
of viscous liquid to be infused.
7
8 The
9 pump can be used for general IV
infusions, blood infusions, antibiotics, lipids, TPN, and enteral
0
feedings. It can be used in continuous
or intermittent mode.

Contraindications	

The Tohamadi pump is not to be used for insulin, pain medication,
or antispasmodics. It is not for use in children under 5 years of age.

Risks	

Risks related to the TOW 724 infusion pump include incorrect
therapy, including overdose or underdose or delay in therapy.
In rare instances, an air embolism may occur.

Customer Service: 1-800-555-1212

www.tohamadi.com

Last Updated: 02/25/2010

Report problems to the Food and Drug Administration at: 1-800-FDA-1088
or online at http://www.FDA.gov/Safety/Report

1

Instructions for Use
How to Operate the Pump

1.	Verify you have the custom tubing and the pole clamp.
2.Connect the pump to the charger. Mount the charger on an IV pole.
3.	Connect the charger to the power cord and into a standard AC outlet.
4. Open the door and thread infusion catheter through pump
mechanism. Close the door.
5.	Connect the infusion set to the medication bag. Mount the bag
on the IV pole.
6.	Prime the primer line.
7.	Connect the infusion set to the patient.
1
2
3
8.	Press the START
button once. You will hear 4 beeps and the
4
5
6
display screen will
light up.
7
8
9
9.	The pumpE1 is02now
ready to use.
C3

Programming the Pump

7
8
9
1.1 Press
the PAUSE
button to see the volume to be infused
2
3
4
5
6
E 0 C
will read
4 (Screen
5
6
7
8 VTBI).
9
1
2
3
7
8
9 UP
0 C
2.	Use
orE1 DOWN
button to adjust the volume or enter the
42 53 6
E 0 C
on the4 keypad.
75 86 9
1 volume
2
3
09 Csave the VTBI.
3.	Press
4
5
6 ENTER7 E8 to
1
2
3
7
8
9
E
0
C
4.	Use UP
or DOWN
button to adjust the rate or enter the rate
4
5
6
E 0 C
on the keypad. 7 8 9
0 Csave the rate.
5.	Press ENTER E to
1
2
3
6.	Press START
to begin the infusion.

4

5
1

6
2

3

Enter

Enter

For Battery Operation and
to Use the Pump in Transit

1

2

3

4

5

6

4

1

2

3

4

5

6

7

8

9

1

02

3

4

5

6

5

7

6

Enter

2

3

4

5

6

7

8
1
0

9
2

1

4
2

5
3

6

48

7 9
5

8
6

9

8

Clear

Clear

Clear

9
Enter

7
8
9
Lift the latch
at
the top of the pump where it is attached to the charger.
1
2
3
E 0 C
The pump will4 release
from the charger.
5
6
0

7

8

9

Enter

1

2

3

7

Clear

E 0
Press the CLEAR
1
2
3
4
7

5
8
0

9

1

4

2

5

3

6

7
8
9
Press the 4PAUSE
5
6

To Stop the Pump

Press the STOP

7

E

8

0

9

C

1
0

2

4

5

7

8
0

Enter

E

2

0

3

4

5

6

8

9

0

1

2

3

4

5

6

7

8

7

3 Enter Clear

Clear

Enter

button.
3

Clear

6

button.
9

button to stop the infusion.

1

C

0
9

8C

7

6

To Pause or Reprogram

Warnings and Precautions	

Enter

1

0

To Clear All Programming

Clear

Clear

Enter

Clear

9

This pump has not been tested for administration of infusion to pregnant
women. Use only accessories designed for this system. Do not reuse
tubing or other disposables. Do not use in the presence of flammable
anesthetics.
Enter

0

1

2

3

4

5

6

1

2

7

3

8

4

5

7

8

0

9

Clear
Enter

Clear

6
9

Cleaning the Pump	

For general cleaning, clean the exterior surfaces with a damp cloth.
For disinfection, use only cleaners listed in the full device labeling.

Compatible Accessories	

The following accessories are compatible with the Tohamadi pump:

	

•  Custom Tohamadi 9.2” intravenous tubing
•  AC adapter/charger
•  Rechargeable battery pack
•  Reusable pole clamps

	
	

0

2

Common Alarms/Troubleshooting
1

Alarm

2

3

6
Troubleshooting

Air In Line

Battery Low

4

5

7

8

1

2

3

4

5

6

0 C
7
8
9
•  Press ESTOP      or
PAUSE     .
E 0 C
•  Check the tubing is properly inserted.
•  Remove air from the line by closing clamps, disconnecting
the pump from the patient, and priming the fluid path.
1
2
3
•  Press START      to
restart the pump.
4

5

7

8

6
9

Enter

C

Clear

•  Plug cord into AC electrical source within 10 minutes.
11

Occlusion

9

E

22

0

33

Enter

44

55

66

11

22

33

77

88

99

44

55

66

7

8

9

Clear

0 C
7
8
9
•  Press ESTOP      or
PAUSE     .
E 0 C
•  Open clamps and check for a bend or kink in the tubing.
•  Check the occlusion pressure setting.
•  Check the IV site for signs of infiltration.
1
2
3
1
2 obstruction
3
•  Remove the
and press START      to
restart the
4
5
6
pump. 4 5 6
0

0

Enter

Volume Low

1

2

3

4

5

6

7

78

89

Clear

Enter

7

9

•  Press the STOP      button.
•  Change the medication bag.
•  Restart
1 the
2
3 infusion.
1restart
2
3 the pump.
1 5 2 6 3
•  Press 4START      to
Enter

1

2 0 3
E

4

5

6

1

2

3

7

8

9

4

5

6

7

8

9

0

Clear

C

0

E

8

9

0

C

Clear

0

Door Open

7 4 8 5 9 6

4

E 7 0 8 C 9

7

5

6

9
•  Press STOP      or PAUSE     .
E 0 C
E 0 C
•  Check that the tubing is aligned properly in the pump.
•  Check to make sure the latch is in the proper position.
•  Close door.
1
2
3
•  Press START     .
8

Enter

Enter

1

2

3

4

5

6

7

8

9

Clear

4

5

2

3

4

5

6

7

8

9

Clear

0

0

Display Does not Light

1

6

If operating
7
8 on
9 battery power, the battery may need recharging.
E 0the
C power cable to the pump and plug it into a
•  Connect
regular 120V outlet.
•  Check to make sure the power cables are firmly attached and
the pump is switched to the ON position.
Enter

Enter

Enter
Clear

1

2

3

4 1

5 2

6 3

7 4

8 5

7

0 8

1

2

3

9 6

4

5

6

9

7

8

9

Clear

Clear

0

0

Refer to full device labeling for more information on alarms.

Enter

1

2

3

4

5

6

7

8

9

Clear

0

3


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File Modified2011-10-11
File Created2011-09-14

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