Attachment E - Label Version 1

Attachment E - Label Version 1.pdf

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Attachment E - Label Version 1

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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

Customer Service: 1-800-555-1212

Display
Screen

Charger

Battery
Charge
Indicator
Numeric
Keypad

1

2

4

3

5

7

6

8

E

9

0

C

Last Updated: 01/25/2010

www.tohamadi.com

START Button
1

2

3

ALARM Button

Door
Latch

4

5

6

PAUSE Button

7

8

9

Infusion
Catheter
Line In

E

0

C

AC Adapter

Description	

Uses 	
Enter

1

2

4

3

5

7

8

Clear

6
9

0

Contraindications	
	
	

STOP Button
CLEAR Button
ENTER Button

• Single channel large volume infusion pump
• Features:
– flow sensor
– alarms for occlusions, air in line,Enter
and low battery
– no lockout mechanism
1 pole
2
3
Clear
– can be mounted on

	
	
	
	
	
	
	
	
	
	
	

UP/DOWN Buttons

4
5 infusions
6
• Continuous or intermittent
of viscous liquids:
– general IV fluids 7 8 9
– blood
– antibiotics
0
– lipids
– TPN
– enteral feedings

• Not to be used for:
– insulin
– pain medication
– antispasmodics
• Not for use in children under 5 years of age

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

1

Risks	
	
	
	
	

•
•
•
•
•

Air embolism
Delay in therapy
Incorrect therapy
Overdose
Underdose

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.
9
9.	The pumpE71 is 280now
ready to use.
3
C
4

Programming the Pump

5
1
8
4
0
7

6
2
9
5
C
8
1
E 0
1 42

3

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

Enter

Enter

For Battery Operation and
to Use the Pump in Transit

1

2

3

4

5

6

7

8

9

1

2

3

4

5

6

7

8

9

1

20

3

4

5

6

1

4

5

7

6

2

3

5

6

7

8
1
0

9
2

3 Enter Clear

4

5

6

Warnings and Precautions	

Clear

Enter

0

Enter

1

2

3

1

4

5

6

7

Clear

48

8
0

2

7

E 0
Press the CLEAR
1
2
3
7

9

1

4

2

5

3

6

7
8
9
Press the 4PAUSE
5
6

7

To Stop the Pump

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

7

To Pause or Reprogram

Clear

9

0

To Clear All Programming

Enter

4

8

Clear

Clear

E

8

0

9

C

Press the STOP

59

8

8C

0

6
9

1
0

2

4

5

7

8

Clear

9
Enter

button.
3

Clear

6

button.
9

0

Enter

button to stop the infusion.

1

E

2

0

3

4

5

6

7

8

9

0

1

2

3

4

5

6

7

8

C

3

Clear

Enter

Clear

• 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.
9

Enter

0

	
	

Cleaning the Pump	

1

2

3

4

5

6

1

2

7

4
7

3

8

5
8

0

9

Clear
Enter

Clear

6
9

• For general cleaning, clean exterior surfaces with a damp cloth.
• For disinfection, use only cleaners listed in the full device labeling.
0

2

Compatible Accessories	
	
	

•
•
•
•

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

Common Alarms/Troubleshooting
1

2

4

5

7

8

6
Troubleshooting

Alarm
001

Air In Line

002

Battery Low

004

005

Occlusion

Volume Low

Door Open

9

1

2

3

4

5

6

9
• Press STOP
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.
E

1

0

4

2

C

5

3

7

8

6

Enter

9
• Plug 4cord
source within 10 minutes.
1
2
3
5
6into AC electrical
1

003

3

7

•
•
•
•
•
•
•
•
•

7

E

4

2

8

8
0

5

3

9

C

Enter

Clear

4

5

6

6

1

2

3

9

4

5

6

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
Remove the
and press START
to restart the
1
2 obstruction
3
4
5
6
pump. 4 5 6
7

8
0

0

Enter

1

2

3

4

75

86

Clear
Enter

7

9

Press the STOP
button.
Change the medication bag.
1
2
Restart
the3 infusion.
1
2
3
4
5
6
1
2
3
Press 7START
to 4restart
the pump.
5
6
8
9
1

2

7

4

5

7

8

E8

3

09

Enter

Clear

C

6

1

2

3

9

4

5

6

7

8

9

0

0

E

8

9

0

C

Clear

0

4

5

6

0 C
7
8
9
• Press ESTOP
or PAUSE
.
7
8
9
E 0 C
• CheckEthat
the
tubing
is
aligned
properly in the pump.
0 C
• Check to make sure the latch is in the proper position.
• Close door.
1
2
3
• Press START
.
4
5
6
If operating
on9 battery power, the battery may need recharging.
7
8
• Connect
E 0the
C power cable to the pump and plug it into a
regular 120V outlet.
• Check to make sure the power cables are firmly attached and
the pump is switched to the ON position.
Enter

Enter

1

2

3

4

5

6

7

8

9

Clear

Display Does not Light

2

3

4

5

6

7

8

9

Clear

0

0

N/A

1

Enter

1

2

4

3

5

1

7

6

2

8

4

3

5

6

8

9

1

2

3

4

5

6

7

8

9

Clear

Clear

9

0

7

Enter

Clear
Enter

0

0

Refer to full device labeling for more information on alarms.
1

2

3

4

5

6

7

8

9

Enter

Clear

0

3


File Typeapplication/pdf
File Modified2011-10-11
File Created2011-10-03

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