CONCEPT / 7-2-2006

MMMAAANNNUUUAAALLL

Infusion Pump

PPPEEEGGGAAASSSUUUSSS LLLAAABBB Light / Vario

Basal Mode

Manual Pegasus Lab

7-2-2006 Page 1 of 30

Contents Page 1. Introduction 2 1.1 Intended use 2 1.2 Disposables and Accessories 2 1.3 Applications 3 2. Construction and Function 4 3. Menus 6 4. Modes of Pegasus Lab 6 5. Inserting / Changing batteries 7 6. Programming Pegasus Lab 10 7. Set-up Menu 1 11 7.1 Set-up menu in the basal mode 11 7.2 Set-up mode in the chrono mode 12 8. Preparing Pegasus for Infusion 13 8.1 Priming 13 9. Software for Profiles Chrono 14 9.1 Preparing Pegasus 15 9.2 Preparing the Pega Interface 15 9.3 Connecting Pegasus and the Pega Interface 15 10. Altering the configuration 16 11. Profiles 17 11.1 Creating a 24-hour profile 17 11.2 Saving a Chrono profile 19 11.3 Printing a Chrono profile 20 12. Profile transfer from the PC to Pegasus 20 12.1 Selecting the profile 20 12.2 Up-loading a profile 21 13. Possible errors during data transfer 22 13.1 No response from pump 22 13.2 Wrong com port 22 13.3 Profile and pump do not correspond 22 14. Alarm functions 23 14.1 Signals 23 14.2 Finding and correcting errors 24 15. Cleaning, Technical servicing and Functional test 26 15.1 Cleaning 26 15.2 Technical service 26 15.3 performance testing 27 16. Technical data, delivery details and accessories 27 16.1 Technical data 27 16.2 Protection against over/underdossage 28 17. Appendix 28 17.1 Warranty 28 18. Accuracy Diagrams (Trumpet Curves) 29 18.1 Pegasus Vario 29 18.2 Pegasus Light 30 Contact details 30 Description of signs used in these instructions Actions

Very important points – consult the manual Before using, consult the manual for the basal mode if the infusion pumps Pegasus LAB and the respective manual of disposables. For other configurations, please consult the respective manual.

Manual Pegasus Lab

7-2-2006 Page 2 of 30

1. Introduction 1.1 INTENDED USE Pegasus is a volumetric micro infusion pump for parental administration of medication and exists in two different variations: Pegasus Vario – double piston driven – Flow rates from 0.01 ml/h – 15 ml/h Programmable in steps of 0,01 ml/h Accuracy: ± 2% Option for ml or mg Pegasus light – peristaltic driven – High flow rates from 0,1 ml/h – 100 ml/h Programmable in steps of 0,1 ml/h Accuracy: ± 5% Option for ml or mg Pegasus LAB is quite simply the most advanced Lab Animal Pump available, a combination of sophisticated hardware and custom software developed exclusively for Lab Animal research. Our development lab is continuously updating Pegasus for improved Lab Animal function. In response to the requests of Lab Animal Research the following unique features have been developed:

- Start/Stop time and date programmable on the pump - Telemetry connection between pump and PC - Real-time Monitoring software (checks on pump status from PC)

Pegasus Lab is designed to provide the ultimate in “hands-off: tetherless infusion via Remote Control by Infrared (IR). The telemetry-system is available on request. 1.2 DISPOSABLES AND ACCESSORIES The following disposables and accessories are available: PEGALine, PEGA Tube L or PEGA Pump HEAD V, PEGA Combiline L, PEGA BAG, PEGABOX, Strong box, PEGA Power SUPPLY, PEGA INTERFACE and LAB IR Telemetry-system as well as accompanying software. PEGA POWER SUPPLY with adapter for the battery compartment is employed if batteries or rechargeable batteries cannot be used. The reservoir contains the liquid medication. After filling the reservoir, the Luer Lock on the reservoir is connected with the Luer Lock of the pump disposables. The filled bag must be primed before being used. PEGA box is available for reservoirs of 50ml, 100ml and 150ml, the strong box can contain the pump and a PEGA bag ≤ 100ml and protects the pump against chocks. Disposal of accessories must be conform to local medical waste regulations.

Manual Pegasus Lab

7-2-2006 Page 3 of 30

1.3 APPLICATIONS The on-board keypad makes possible configuration and initiation of continuous infusion profiles with the pump in hand, while intermittent or custom profiles can be entered via the PC software with aid of the PEGA Interface. Starting and stopping and operation of the pump can also be done from the PC, as can modification of the delivery profile. Pegasus is shipped in the basal mode (continuous flow). No additional equipment, PC or software is required to run Pegasus in the basal mode. All pump programming is done on the pumps keypad and LCD. With aid of the PEGA Interface, PC and the respective software, PEGASUS can be configured into the chrono mode (custom profiles) and back in the basal mode. PEGASUS may only be in ONE MODE at a time. However, it is possible to switch between the modes via the PC as often as desired. Because of the pump’s design safety, the pump moves into a “precautionary mode” when an error occurs. The precautionary mode results in the cessation of pumping and is signalled by alarms. An integrated memory chip in the pump will keep record of interruptions in flow, alarms, program changes, etc. Pegasus can be used for the following drug infusion administration routes: • subcutaneous • intravenous • intraarterial • epidural • intrathecal

It is of utmost importance to read these instructions before operating Pegasus

Manual Pegasus Lab

7-2-2006 Page 4 of 30

2. Construction and Function Front view of Pegasus with display and 4 manual keys.

Rear view after opening the pump lid.

Pegasus Light Pegasus Vario Peristaltic Drive pressure sensor Pega pump head Pega tube

Manual Pegasus Lab

7-2-2006 Page 5 of 30

CONSTRUCTION OF PEGASUS

Red and green LED Infrared Interface Display Plug for Interface Box

Special key Numeric key Next key Enter/Save key Battery compartment

Manual Pegasus Lab

7-2-2006 Page 6 of 30

3. Menus PEGASUS LAB has 3 menus:

1. Set-up menu 1 for programming Accessed by code 1 – 3 – 2 2. Set-up menu 2 for changing the bag content

Accessed by code 1 – 1 – 1

3. Information menu Without code – any key

In the information menu, if no key is pressed during 15 seconds, the background light of the display switches off automatically to save energy.

4. Modes of Pegasus LAB The acoustic signals and alarms can be silenced at any time, no access code is needed! For silencing the acoustic signals • Press the next key ↵ and the special key simultaneously For turning up the acoustic signals • Press the next key ↵ and the special key simultaneously

PEGASUS LAB operates in two modes:

a. BASAL MODE In the basal mode PEGASUS can be programmed directly on the pump without PC, see the chapter 7.1, page 11. b. CHRONO MODE Customised profiles can be programmed in PEGASUS- chrono mode. The profiles can be created with the PumpProgrammer (see chapter 11, page 17) and then transferred into the pump (see chapter 12, page 20). In the chrono mode with an appropriate profile, several parameters can be programmed directly on the pump, see the chapter 7.2, page 12.

Manual Pegasus Lab

7-2-2006 Page 7 of 30

5. Inserting/Changing batteries

* Insert batteries when the pump is initially connected. * Change the batteries when the battery alarm signal comes on Pegasus operates using either disposable batteries or rechargeable batteries. A fully charged battery contains only approximately 40% (NiCd) or 70% (NiMH). A new

alkaline battery contains 80% of the energy contained in a new lithium battery. The life of the batteries and

the resulting infusion amount depends on the chosen flow rate. At the maximum flow rate, a set of new batteries would supply enough current to infuse at

least the following fluid volume: PEGASUS VARIO PEGASUS LIGHT

To insert the batteries

Place the pump on a flat surface with the display facing up Slide the lid of the battery compartment upwards Pull out the removal ribbon for the batteries

Flow rate of 5ml/h Flow rate of 7,5ml/h Flow rate of 10ml/h Batteries reach duration reach duration reach duration

Lithium 180 ml 36 h 200 ml 27 h 220 ml 22 h Alkaline 140 ml 29 h 160 ml 21 h 175 ml 18 h NiMH 125 ml 25 h 140 ml 19 h 150 ml 15 h NiCd 70 ml 14 h 80 ml 11 h 90 ml 9 h

Flow rate of 50ml/h Flow rate of 10ml/h Batteries reach duration reach duration

Lithium 1.000 ml 20 h 850 ml 85 h Alkaline 800 ml 16 h 650 ml 65 h NiMH 700 ml 14 h 550 ml 55 h NiCd 400 ml 8 h 350 ml 35 h

Manual Pegasus Lab

7-2-2006 Page 8 of 30

Follow the indication inside the battery compartment how to insert the batteries. The removal ribbon must be placed in an “S” shape around the batteries. Only in this position can the batteries be pulled out by the removal ribbon.

Insert two 1,5 volts batteries or two 1,2 volts NiCd/NiMH batteries Place the end of the removal ribbon between battery and housing.

There is a small mark at the right and left top of the lid of the battery compartment.

Place the lid of the battery compartment on the pump so that the markings correspond with the upper side of the pump.

Slide the lid onto the battery compartment

When the batteries are inserted, Pegasus is automatically switched on. If old batteries or NiCd batteries are inserted, the display will show: ->= battery ↵ = NiCd batt

Press the corresponding key. An acoustic signal is given. The display will show:

Pega Pega Vario LAB Or Light LAB

System test System test

Manual Pegasus Lab

7-2-2006 Page 9 of 30

Technical service is required on Pegasus Vario every two years, on Pegasus Light once a year. When the next service is due within the next weeks, the display will show:

Service Service Required or, if servicing missed ==== is already overdue ======

If the service reminder is shown or the deadline is already missed, send Pegasus immediately to the sales representative for service. If the pump is used after the service deadline, product functionality can no longer be guaranteed and the product warranty expires. After 30 – 40 seconds the display will show: System test finished If an error occurs or an alarm appears, see chapter 14, page 23. After the self-test is ended, the display will show: Pump Interrupted

= info ↵ = set-up

When the batteries have been changed during therapy, the data remain stored.

Press the enter/save key ↵ The display will show: Enter code -0-0-0- * = start

Press the bolus-special key

Manual Pegasus Lab

7-2-2006 Page 10 of 30

The display will show: Enter code -0-0-0- ↵ = start

Press the enter/save key ↵ The pump continuous then with the interrupted program. If no key is pressed for 15 seconds the background light of the display will automatically turn off to save energy. After inserting the batteries the background light will turn off after approx. 3 minutes. Upon pressing any key, the background light turns on again.

6. Programming Pegasus LAB For programming Pegasus Lab, the code –1-3-2- has to entered (for changing only the reservoir content, enter the code –1-1-1). To enter set-up menu (1-3-2)

Press the enter/save key ↵ The display will show: Enter code -0-0-0- ∗ = start

Press the numeric key once: -1–0–0- Press the next key once: -1–0-0- Press the numeric key nine times: -1–3–0- Press the next key once: -1–3-0- Press the numeric key twice: -1–3–2- Press the enter/save key ↵

The display will show: Enter code - okay - A display test will follow automatically.

Manual Pegasus Lab

7-2-2006 Page 11 of 30

The display will show: Service (a date will be shown here) Required =====

The date of the next service is shown in the set-up menu (see chapter 5, pag 9). During the 4 weeks preceding the next service, a reminder is given every time the batteries are replaced. If the service reminder is shown or the deadline is already missed, send the pump immediately to the sales representative for service. If is pump is used after the service deadline, product functionality can no longer be quaranteed and the product warranty expires. The pump is now in the “set-up” menu. 7. Set-up menu 1 7.1 Set-up menu in the basal mode Pegasus can be programmed directly on the pump following the indications of the display. In the Set-up menu code –1-3-2- the following parameters appear in the display and van be programmed: The parameters of the set-up menu are accessed by pressing the next key

- flow rate basal continuous flow rate of the medication either in ml/hr

or mg/hr (concentration mg/ml) - bag content amount of medication to be initially filled into the reservoir - starting time & set-up a delayed start and/or programme end an earlier end if needed - priming catheter priming the infusion set with the maximum flow rate to

eliminate air. - time and date local time (when moving time zones or change of

summer/winter time) can be set up For setting time and date use the next key to scroll through

the set-up menu beyond the starting display.

If the date and/or time on the pump are changed please note that the parameters must be corrected or brought up to date after a change of the time and/or date.

Manual Pegasus Lab

7-2-2006 Page 12 of 30

For programming the parameters Press the enter/save key ↵ and enter the code, see chapter 6, page 10.

The flashing cursor indicates which parameter can be set.

Set the parameter with the numeric key Choose the parameter with the next key Set the parameter with the numeric key Etc. To save set and/or changed parameters Press the enter/save key ↵ For safety’s sake, the newly entered parameters appear again in the display.

7.2 Set-up menu in the chrono mode The following parameters can be set on the keypad of the pump. * The parameters of the set-up menu are accessed by pressing the next key

- bag content amount of medication to be initially filled into the reservoir - starting time & set-up a delayed start and/or program end an earlier end if needed - priming catheter priming the infusion set with the maximum flow rate to

eliminate air. - time and date local time (when moving time zones or change of

summer/winter time) can be set up For setting time and date use the next key to scroll through

the set-up menu beyond the starting display.

If the date and/or time on the pump are changed please note that the parameters must be corrected or brought up to date after a change of the time and/or date. For programming the parameters

Press the enter/save key ↵ and enter the code, see chapter 6, page 10.

The flashing cursor indicates which parameter can be set. Set the parameter with the numeric key Choose the parameter with the next key Set the parameter with the numeric key Etc. To save set and/or changed parameters Press the enter/save key ↵

For safety’s sake, the newly entered parameters appear again in the display.

Manual Pegasus Lab

7-2-2006 Page 13 of 30

8. Preparing Pegasus for Infusion

Danger of infection All these steps must be carried out on a clean surface. Disinfect hands beforehand and do not touch open Luer connections Insert the pump disposables following the respective. Prime the infusion set before starting the pump. 8.1. Priming Before connecting the pump to the animal, the infusion system must be primed. When priming the infusion system, the function of the pump will be checked at the same time. In the set-up menu

Press the next key until the display shows: catheter -> = next ↵ = prime

Press the enter/save key ↵

The display will show: Priming * = pump = .. ml

↵ = prime Either * Press the bolus/special key until the catheter system is primed Or * Press the numeric-key once The pump will automatically administer 2 ml (Lab Light) or 1 ml (Vario) • Press the enter/save key ↵ ���������������������b ackground light during the priming, * Press the next key or the special key

Manual Pegasus Lab

7-2-2006 Page 14 of 30

When priming the patient line in the set-up menu 2 , (code –1-1-1-) a maximum of 5ml (Lab light) or 2ml (Lab Vario) van be demanded within 10 hours! Prime the catheter system until a drop of medication forms at the end of the catheter. A delayed start or an earlier end of the program can be entered. For setting time and date * use the next key to scroll through the set-up menu until the starting display. The display shows: Parameters = next

↵ = end / start pump

* Press the enter/save key ↵ The set-up menu will automatically end and the pump begins the programme. The green signal lamp flashes at regular intervals to indicate pumping. The pump is now in the information menu, with the next key all information can be scrolled up. Pegasus pump is designed to prevent retrograde flow. If Pegasus is in parallel with another infusion apparatus (“piggybacked”), it is important that the other infusion apparatus have protection from retrograde flow, such as a back-check valve. 9. Software for Profiles Chrono Install the program PumpProgrammer onto the PC following the instructions on the PC screen. If wanted, create an Icon on your PC. • Launch the program PumpProgrammer • Open in the menu “Tools”, then “General Configuration” • Enter the Com Port selected for the PEGA Interface and the Data transfer • Change the “default chrono profile directory”, if wanted

Manual Pegasus Lab

7-2-2006 Page 15 of 30

9.1. Preparing Pegasus • Insert batteries (see chapter 5, page 7) For altering the configuration or loading a new profile, select on Pegasus the data transfer via cable or IR • Using the next key to scroll through the set-up menu beyond the starting

display. Prior to the data transfer, Pegasus has to be stopped • Pressing the enter key ↵ and numeric key simultaneously Pegasus is receptive for data transfer via IR during 3 minutes, than after pressing any key. For the data transfer via cable, it is not necessary to press any key. 9.2. Preparing the PEGA Interface • Insert 1,5 volt battery in the interface with the +-pole facing battery

compartment lid The green LED will illuminate for a few seconds. If the green LED does not turn on, the battery is depleted or incorrectly inserted. I the red LED turns on, the interface battery is weak: • Insert a new 1,5 volt battery If no LED is lightening, no or a depleted battery is in the Interface: • Insert a new 1,5 volt battery 9.3. Connecting Pegasus and the PEGA Interface The PEGA Interface offers the following possibilities for the data transfer: a) Wireless data transfer via the integrated infrared system (IR) Align the pump with the infrared detector of the interface. b) Data transfer via the transmitter cable Connect interface and the pump. Insert the plug into the socket for Pega Interface at the left side of the pump.

Manual Pegasus Lab

7-2-2006 Page 16 of 30

10. Altering the configuration PC, Pump and PEGA Interface are prepared and connected. For altering the configuration, • Launch PumpProgrammer double clicking on the Icon • Open the tab “Configure Pump Model” • Select the pump model • Enter the pump SN – only this pump will be called • Click on “any”, and pump will be called • Call pump to check the connection If a message box appears with the SN of the pump, the connection between the pump and PEGA Interface is correct and the configuration can be chosen, if necessary. In the window “log” the actions are confirmed. Error messages, see chapter 13, page 22. After the configuration s successful done, the message box appears “Profile:…. Uploaded successful”.

* Click on OK. Now a chrono-profile can be transferred, see chapter 12, page 20, to create a profile, see chapter 11, page 17.

Manual Pegasus Lab

7-2-2006 Page 17 of 30

11. Profiles 11.1. Creating a 24-Hour profile With the PumpProgrammer it is possible to edit custom delivery patterns over the 24-hour period, creating a fluid delivery scheme. * Launch the PumpProgrammer on the PC * In the menu open “File” and select “New” The window “new Profile” opens

• Select the pump model The program indicates the minimum and maximum flow rate step for the chosen model • Select the unit (ml/h, mg/h) • If mg/h is selected, enter the concentration • Enter the default bag volume The bag volume can be changed later, even on the pump • Click on OK For editing a Chrono Profile, either the mouse or the keypad can be used. Some important items of clarification, before proceeding in this section:

- this is a method for defining delivery rates (flow rates) in specified time blocks according to a 24 hour scheme

Manual Pegasus Lab

7-2-2006 Page 18 of 30

- 24-hour clock time designations will be used in this section, not a.m. and p.m.

- the frame of reference will be the pump’s time setting – first segment at 02:00h, which can be altered

The start time of the first segment is NOT the start time of the pump. When the

pump is activated, it starts with the corresponding segment for the current time and begins IMMEDIATELY with the flow rate set.

Breaks in therapy must be entered a separate segments with starting time, duration and flow rate “0”. To enter in “edit mode” • Press F2 button or click with the mouse into a cell of the profile grid. The duration of the selected segment has to be entered as 0:00 and the flow rate as offered, e.g. 0,0ml for Lab light and 0,00 for Lab Vario. A leading zero can be omitted, but not the colon between hours and minutes. • Press

↵ ������������������ ������������������ It is also possible to enter the edit mode by clicking into a cell of the profile grid. A new segment is always created and appended, when entering a duration in the last segment and the sum of duration of the programmed segments is inferior of 24:00hours. The duration of the last segment is always calculated in a way that the sum of the duration of all segments is 24: hours. It is possible to insert and delete segments, opening the context menu either

- by pressing the right mouse button - opening in the menu entry “edit” - Click on “insert segment” or “Delete Segment” or press Shft + ins or Shft +

del The dose per day is indicated in the field “Dose per day”. The bag volume can be edited in the edit-field “Bag content”. The bag content can be changed later, if wanted – even on the pump. Before up loading or printing, the file has to be saved.

Manual Pegasus Lab

7-2-2006 Page 19 of 30

11.2. Saving a Chrono Profile For saving the chrono profile, name this specific pattern of fluid delivery – up to then characters. This should be a meaningful name, easily distinguishable from names of other patterns that will be designed. • Click on “File” on the menu entry • Open “Save” • Enter the name of the profile with max 10 characters • Click OK The file is saved in the default directory as C:\Programme\Pegasus\PumpProg\data. The default directory can be changed in the “tools” under “General Configuration”. The current date and a profile number are added to the filename automatically. Example: name of the profile doggy-p20 The file is saved as : doggy-p20_31021.1124_06 #036.xml 3 10 21. 11 24_ 06# 036

a) year b) month c) day d) hour e) minute f) chrono g) consecutive number

It has been saved October (b) 21 (c), 2003 (a) at 11(d):24(e)hours f) 06 is recognized as a chrono profile,

h) 036 is the consecutive profile number created and saved on this PC.

The profile must not be renamed manually, this can create conflict in the program/pump! When changing an already existing program, it is possible to save it under the original file name of a new name:

- Click on “File” in the menu entry For the same name

- Click on “Save” The file will be saved using the same profile name adding automatically the current date and a profile number to the file name.

Manual Pegasus Lab

7-2-2006 Page 20 of 30

- Click on “Save As…” - Enter a new name of the profile with max 10 characters The program will save this file under the new name without overwriting the previous file adding automatically the current date and a profile number to the file name.

11.3. Printing a Chrono Profile the chrono profile will be printed under Adobe Acrobat reader, which has to be installed on the PC (download www.adobe.com or install from the CD). For printing a profile, it has to be saved first.

- Click on “File”, then “Print” - Follow the indications in the program.

The printout of the profile can be signed and archived. To avoid problems with the print quality, choose the option “print as image” in the print dialog of Acrobat Reader.

- On the print-out compare the protocol with the wanted administration scheme.

Recommendation: To avoid mistaken identities, a copy of the protocol may be attached to the infusion bag being used or put into the pump bag.

If the protocol and the chosen profile correspond, we suggest signing the protocol and filling it in the dossier. 12. Profile Transfer from the PC to Pegasus For the data transfer Pegasus, Pega Interface and the PC have to be prepared, see chapter 9, page 15. 12.1. Selecting the profile When Pegasus, the Pega Interface and the PC are prepared and connected with one another

- launch PumpProgrammer double clicking on the Icon - Click “File”, then ‘Open” - Select and open the profile which will be uploaded

The selected file will be displayed. - Enter the pump SN – only this pump will be called or - Click on “any” – any pump will be called - Click on “Call pump” to check the connection

Manual Pegasus Lab

7-2-2006 Page 21 of 30

The message box appears with the SN of the pump. The connection between pump and Pega Interface is correct and the profile can be up-loaded. 12.2. Up-loading a profile For up-loading the selected profile

- Click on “up-load profile” Error messages, see chapter 13, page 22. After the configuration is successful done, the message box appears “Profile: … uploaded successful”.

Recommendation: To avoid mistaken identities, a copy of the protocol may be attached tot he infusion bag being used or put into the pump bag.

If the protocol and the chosen profile correspond, we suggest signing the protocol and filling it in the dossier. On the protocol and Pegasus display the identical ID number, file name and programme number will always be indicated.

Manual Pegasus Lab

7-2-2006 Page 22 of 30

For setting-up and starting Pegasus, see chapter 7.2, page 12 and chapter 8, page 13. 13. Possible errors during data transfer 13.1. No response from pump When the following message box appears,

make sure that the correct connection (IR or cable) has been selected, pump and PEGA Interface are correctly connected or aligned and that Pegasus is receptive, see chapter 9, page 15. 13.2. Wrong com port When the following message box appears,

• Open in the menu “tools”, then “General Configuration” • Enter the correct Com Port. 13.3. Profile and pump do not correspond Only profiles with the parameters set for the pump model can be chosen. If the selected profile does not correspond to the selected pump, a message box appears

Manual Pegasus Lab

7-2-2006 Page 23 of 30

• Click on “OK” and select the profile appropriate to the pump. 14. Alarm Functions 14.1. Signals It is possible to silence all acoustic signals and alarms in the set-up men, see chapter 7.2, page 12. When the acoustic signals are not silenced, following warning signals and pauses will sound:

- intermittent signal with a one-second tone / pause: “Bag empty” - intermittent signal with a half-second tone/pause: “Occlusion” - intermittent signal with a one-second tone/ten-seconds pause: All other

alarms During operating disruptions, the warming signals will be accompanied by explanations and instructions in the pump display. This acoustic warning signal can be silenced for approximately five minutes. The following will appear in the display: Catheter Occlusion! = mute

↵ = edit

* Press the Numeric-Key ; the acoustic warning signal will be silenced for approximately five minutes. (N.B.: the pump is not administering at this time!) In the set-up menus, a short tone will sound every 15 seconds.

Manual Pegasus Lab

7-2-2006 Page 24 of 30

14.2. Finding and correcting Errors Pegasus contains an in-built control function that continuously supervises the chosen therapy in order to ensure maximum safety. If an error occurs, the pump gives acoustic (if not silenced!) and optical alarms. It is always possible to continue the therapy program after having corrected the error, as all chosen parameters remain saved. The following table shows messages, causes and remedies.

Alarms Cause Correction

RE

D L

ED

1. Bag is empty! = mute ↵ = edit

Medication supply in Pegasus Bag is running out

Changing Infusion System

2. BATT

Limited Life left in batteries

Max. 20% of the battery capacity is left. Insert new batteries

3. Battery Is weak! ↵ = edit

Limited life left in batteries

Insert new batteries

RE

D L

ED

4. Battery Is empty!

Batteries are empty. Infusion can stop at any moment and a new infusion cannot be started.

Insert new batteries

5. No display

1. No or empty batteries.

Alarm may sound for up to 15 min. if the interruption occurred during operation

2. Technical faults in pump

Insert new batteries. If error is not repaired, return pump to local sales representative for service

6. Warning! Aux. Battery Is empty!

No internal energy source

Return pump to local sales representative for service

Manual Pegasus Lab

7-2-2006 Page 25 of 30

7. Service Required sooner

The black box in the pump is nearly full

Return pump to local sales representative for service

8. Pump interrupted! = mute ↵ =set-up

Pump is stopped

Check parameters, and if necessary, enter new parameters. Restart the pump.

RE

D L

ED

9. Re-enter parameters! = mute ↵ =set-up

If in the set-up menu, no key was pressed for 30 minutes, or the batteries were removed

Check parameters, and if necessary, enter new parameters. Restart the pump.

RE

D L

ED

10. Catheter occlusion! = mute ↵ = edit

Occlusion on the patient side. Needle/filter blocked or catheter/tube is blocked due to kinking

Check the infusion system and resolve the blockage. If necessary, change the infusion system.

RE

D L

ED

11. Please check Pump head! = mute ↵ = edit

Frequent faults in the pump drive/pump disposable

Change the pump disposable

RE

D L

ED

12. Please close Pump! = mute ↵ = edit

The housing clips are not engaged or the pump disposable has not been inserted

Insert pump disposable. Close the pump lid, engage the housing clips.

RE

D L

ED

13. Error XX In YYY! = mute

Technical fault in the pump (faults in code)

Remove the batteries and re-insert. If the alarm reoccurs, return the pump to the representative for service

RE

D L

ED

14. Please check Pump! = mute ↵ =set-up

The pump disposable is damaged

Change the pump disposable and re-start the pump

Manual Pegasus Lab

7-2-2006 Page 26 of 30

15. Pump is off! = info ↵ = set-up

Pump is off. Parameters are set to “0”

Enter new parameters in the set-up menu. Switch pump on

After correction of the cause for the alarm, always press one after the other ↵, and then ↵ , following the indications in the display. This will re-start the pump.

What if the pump is accidentally dropped?

* Check pump, pump lid and Box / for external damage (cracks etc) If the pump is damaged...

* Return pump to representative for service If the box is damaged...

* Replace box If the pump appears undamaged... * Remove the batteries and reinsert The pump should now carry out a system test. If the system test is successfully executed, the pump is operational and can be restarted. If not, return the pump to the representative for service. 15 Cleaning, technical Servicing and Functional test

15.1 Cleaning Wipe Pegasus with a damp cloth. Alcohol-based solution may also be used for cleaning.

15.2 Technical Service The Medical Appliance Act and the Medical Product Law require regular technical servicing. A service check must be carried out on Pegasus Vario every two (2) years, on Pegasus Light once a year. The date of the next service is shown in the set-up menu (see section 5). During the 4 weeks preceding the next service, a reminder is given every time the batteries are replaced. If the service reminder is shown or if the deadline is already missed, send Pegasus immediately to the representative for service. If the pump is used after the service deadline, product functionality can no longer be guaranteed and the product warranty from Pegasus expires.

Manual Pegasus Lab

7-2-2006 Page 27 of 30

15.3 Performance testing The function and correct condition of the pump must be tested before each application. To ensure proper performance, the following test should be conducted; a) Self-test by inserting the batteries (See chapter 5 , page 7), and b) Priming (See chapter 8 , page 13.)

16 Technical Data, Delivery details and Accessories 16.1 Technical Data

Pegasus Vario LAB Pegasus Light LAB

Classification

Type BF Type BF

Housing

ABS, shock proof,

”Splash-proof” protection degree IPX 4

ABS, shock proof,

”Splash-proof” protection degree IPX 4

Dimensions

83,7 x 62,3 x 31,5mm

83,7 x 62,3 x 31,5mm

Weight 150 gr, without batteries

180 gr, without batteries

Batteries 2 x1,5 Volt, size AA

2 x 1,5 Volt, Size AA

NiCd Batteries 2 x 1,2 Volt NiCd/NiMH

2 x 1,2 Volt NiCd/NiMH

Storage temperature

-30˚ C to +70˚C

-30˚ C to +70˚C

Operation temperature

+5˚C to +40˚C

+5˚C to +40˚C

Rel. humidity 30% to 75%

30% to 75%

Flow rate

0,01 ml/hr to 15ml/hr adjustable by 0,01ml

steps

0,1 ml/hr to 100ml

adjustable by 0,1ml steps

Volume

0,1ml to 999,9 ml adjustable by 1ml steps

0,1ml to 1000 ml

adjustable by 0,1ml steps

Accuracy

± 2% or ±2 µl

time: + 0,001 % quartz controlled

± 5% or ±70 µl

Pressure Sensor

Cut-out pressure of 1500hPa in event of

occlusion on the animal side )=200 hPa–100 hPa)

Cut-out pressure of 1500hPa in event of

occlusion on the animal side )=200 hPa–100 hPa)

Manual Pegasus Lab

7-2-2006 Page 28 of 30

16.2. Protection Against Over/under Dosage Each rotation of the drive shaft is registered and checked by two mutually controlling microprocessors. In case of an error, a maximum of 100µl (Pegasus Vario) or 180 µl (Pegasus Light) could be infused. A deviation of the chosen flow rate is identified after a maximum possible over dosage of 0,05ml (Pegasus Vario) or 0,3ml (Pegasus Light) and the pump stops. The following table shows the maximum delays that can occur until the activation of the occlusion alarm:

Under no circumstance may Pegasus be exposed to radiation, x-ray, CT,NMR (MRI), radiation therapy or sonography. Pegasus has a splash-proof housing, few splashes of water will not cause any harm. 17 Appendix 17.1 Warranty The correct function of the infusion pumps is guaranteed for a period of three (3) years from the purchase date. If a notification is given to the representative within the warranty period of defects in materials or workmanship and determined that such notification is correct. Manufacturer reserves the right to repair or replace the defective infusion pump. The warranty is valid only when the defective infusion pump is sent to representative. The transportation costs are the responsibility of the customer. This warranty shall not include:

15 damages caused by unusual events 16 damaged caused by repairs or tampering 17 Negligent care and handling, especially inadequate storage, dropping,

immersion in liquids, unintended uses and disregard of the manual. 18 damage t o any person or object

The infusion pump may only be used under the supervision of qualified personnel.

Pegasus Vario LAB Pegasus Light LAB Flow rate Delay Flowrate Delay 15 ml/h 20 s 100 ml/h 10 s 10 ml/h 35 s 50 ml/h 20s 7,5 ml/h 45 s 20 ml/h 45s 5 ml/h 1 min 10 ml/h 1 min 30s 1 ml/h 3 min 45 s 5 ml/h 2 min 30s 0,5ml/h 5 min 45s 1 ml/h 10 min 0,1ml/h 13 min 0,1ml/h 45 min

Manual Pegasus Lab

7-2-2006 Page 29 of 30

18 . Accuracy Diagrams (Trumpet Curves) The co-ordinate system of the trumpet curve shows in the ordinate (y-axis) the deviation in percentage of the nominal flow rate. In the abscise (x-axis) the observation period is registered. The trumpet curve shows for every observation period the possible deviation of the nominal flow rate. 18.1 Pegasus Vario For Pegasus Vario this means e.g., for the flow rate of 15ml/h: In an interval (observation period) of two minutes, e.g. for Pegasus Vario the maximal deviation (Epmax) of approx. 0,5% and a minimal deviation (Epmin) of approx. -1%. The total error is 0,31%. This is valid for any interval. These small deviations in comparison with the nominal flow rate is the result of the micro-pistons pump head’s micro pulses of 0,4µl.

Manual Pegasus Lab

7-2-2006 Page 30 of 30

18.2 Pegasus Light For Pegasus Light this means e.g. , for the flow rate of 100ml/h: In an interval (observation period) of two minutes, e.g. for Pegasus Light the maximal deviation (Epmax) is approx. 2,5% and a minimal deviation (Epmin) of approx. 2,5%. The total error is 1,5%. Trumpet curve 100 ml/h

For support, disposables and Information, please contact:

UNO Roestvaststaal BV PO Box 15 6900 AA Zevenaar The Netherlands Phone: +31 316 524451 Fax: +31 316 523785 Email: info@unobv.com http: www.unobv.com