PD-Read Plus Training Manual

Headline PD-Paed Plus is part of P³ Sub-Headline

P3 is a comprehensive Peritoneal Dialysis programme P3 allows you to prescribe individual therapy programmes, monitor patient conditions, and precisely adjust therapy when needed – in an

Protect

Preserve

efficient and optimised way. • Protect:

unique and easy-to-understand PD systems

• Preserve: ultra-low GDP fluids • Prolong: individual state-of-the-art therapies for fluid balance control and guided prescription modelling

Prolong

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Content

Introduction ... 4 Material needed . ... 5 System overview ... 6 Recommended handling procedures ... 8 1.

Preparation ... 8

2.

Opening the outer wrapper ... 9

3.

Hand disinfection ... 9

4.

Preparing the system ... 9

5.

Preparing the PD fluid... 10

6.

Priming the system . ... 12

7.

Connecting the patient ... 14

8.

Outflow... 15

9.

Inflow... 16

10.

Dwell... 16

11.

Disconnecting the patient ... 17

12.

Option: Pause the treatment ... 19 a) Disconnecting with PIN Reload device . ... 19 b) Reconnecting to PD-Paed Plus ... 20

Recommended material... 22 Prescribing information... 23

3

Introduction

The recommended handling procedures for PD-Paed

peritoneal dialysis fluid from Fresenius Medical Care.

Plus produced by Fresenius Medical Care are intended

The availability of the PD fluids mentioned in this manual

to support the clinical personnel. They are not intended

depends on the pharmaceutical product registration in

to replace a proper training on the system by a corporate

the individual countries.

clinical specialist or specific instructions for use of medical devices or medicinal products. Furthermore, they are not

The PD-Paed Plus is intended for maximal 24 hours

intended to replace the judgement or experience of the

use and for single use only. Usage for periods longer

attending physician and nurse. The peritoneal dialysis

than 24 hours and reuse may be hazardous to the

treatment is the sole responsibility of the attending

patient. Cleansing solutions and disinfectants may

physician and nurse.

damage materials employed for the PD-Paed Plus. Safety and performance of use can no longer be

The PD-Paed Plus is an ideal system to start peritoneal

assured and the manufacturer assumes no liability. The

dialysis treatment in small children. It is suitable for a fill

PD-Paed Plus must only be used in conjunction with

volume of up to 200 ml per exchange and/or for children

the peritoneal dialysis fluids listed above by healthcare

below 10 kg. It is intended for clinical use only. The

professionals with the appropriate training, knowledge

PD-Paed Plus is DEHP-free and contains no natural

and experience and for whom proof of instruction can

latex. The present clinical procedures explain the use of

be shown.

the PD-Paed Plus together with a stay•safe®/ Luer-Lock catheter extension. If, for newborns, the stay•safe®

The mixed stay•safe® balance fluid is stable for

catheter adapter is used instead of the catheter extension

24 hours in the PD fluid bag, but once in the PD-Paed

please contact your local Fresenius Medical Care

Plus system it should be discarded after six hours.

representative who will demonstrate the procedure. We reserve the right to perform technical modifications The PD-Paed Plus is intended to be used only with stay•safe® balance or stay•safe® CAPD/DPCA

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without special prior notice.

Headline needed Material PD-Paed Plus Sub-Headline

Material needed:

• Infusion pole • Warming appliance1 • PD-Paed Plus • Burette holder(s) – depending on type of warming appliance • Drainage bag holder • 1 holder for organizer • 2 organizers • CLIP for organizer • Wrapped stay•safe® disinfection cap • 1 scissor clamp • PD fluid bags • Face mask (according to your hospital procedure) • Hand disinfectant/gloves (according to your hospital procedure) 1 Fresenius Medical Care recommends the Barkey Warming System XPT for PD-Paed Plus by Barkey GmbH & Co.KG, Germany, compliant with ISO EN 60601-2-16. For company, product and contact details please visit the Barkey website: www.barkey.de. [Please note the following: The website www.barkey.de is a third party website (“external link”). As the content of such website is not under our control, we cannot assume any liability for such external content. In all cases, the provider of information of the linked websites is liable for the content and accuracy of the information provided. At the point in time when the links were placed, no infringements of the law were recognisable to us. As soon as an infringement of the law becomes known to us, we will immediately remove the link in question.]

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PD-Paed Plus schematic overview

① DISC

③ 2 Bag connectors

Catheter extension

⑨

⑥

Patient Catheter

Patient connector

Y-piece

⑫

⑭

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System overview Complete PD-Paed Plus set-up

① PD fluid ①

② Organizer without CLIP to fix DISC during bag connection ③ 2 Bag connectors ④ Clamps to fill burette ⑤ Burette holder

②

⑥ Inflow burette with safety valve ⑦ Inflow line ⑧ Roller clamp to adjust inflow speed ⑨ Patient connector ⑩ Organizer with holder and CLIP

③ ④ ④

⑤ ⑥

⑪ Outflow line ⑫ Outflow burette

◯

③ ⑧

⑬ Sample/injection port ⑭ Drainage bag

⑩

⑮ Drainage bag holder

◯ ⑨ ◯ ⑬ ⑦

⑫

⑪ ⑮

⑬

◯

⑭

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Headline R ecommended handling procedures PD-Paed Plus Sub-Headline

Two options for patient connection

①

In this manual we are describing the use of the PD-Paed Plus ­system together with a stay•safe® catheter ­extension (option ①). In order to decrease recirculation volume, for example in the treatment of neonates, it is possible to do a shortcut between catheter and

②

PD-Paed Plus system by using the stay•safe® catheter adapter (option ②). Handling space however is limited in this case. ①

②

Catheter

Catheter

+ catheter adapter Luer-Lock

+ stay•safe® catheter adapter

+ stay•safe® catheter extension

+ Patient connector

+ Patient connector

1. Preparation

• Place the infusion pole into position • Attach 2 burette holders to the infusion pole and adjust to height of bed or incubator (option described in this manual) or:

• In case a warming appliance is used: set up the warming appliance according to the manufacturer’s requirements

• Attach holder for organizer to the infusion pole above the lower burette holder. Insert CLIP into the organizer and insert the organizer into the holder

• Attach drainage bag holder to the infusion pole • Clean the work surface • Check glucose concentration, expiry date and volume of the PD fluid as well as the bag and the outer wrapper for possible damage

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Headline R ecommended handling procedures PD-Paed Plus Sub-Headline

2. Opening the outer wrapper

• Put on face mask (according to your hospital procedure) • Check the expiry date and the packaging of the PD-Paed Plus for possible damage

• Open the PD-Paed Plus packaging • Open the outer wrapper of the PD fluid bag without touching the inner part, and leave the bag in the inner wrapping foil

3. Hand disinfection

• Disinfect your hands/put on gloves – according to your hospital procedure

4. Preparing the system

• Pull the drainage bag out of the pouch, remove the pro­tective paper and connect it to the yellow connector of the drainage system

• Close all six clamps of the PD-Paed Plus. Leave the roller clamp open as it is only used for altering the flow speed

• Locate the patient connector and place it into the organizer located above the lower burette holder

• Place the inflow burette in the upper burette holder

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Headline Recommended handling procedures PD-Paed Plus Sub-Headline

• Place the burette of the drainage system in the lower burette holder Note:

• The cap on the vent of each burette should not be loosened or removed. This kind of cap allows air passage even it is screwed on completely

• Attach drainage bag to the drainage bag holder. Stop cock is already in closed position.

5. Preparing the PD fluid bag

• Disinfect your hands thoroughly/change gloves – according to your hospital procedure

Mixing the PD fluid when using a double-chamber PD fluid:

• Check that the Lambda seam is intact before opening it • Apply pressure by rolling up the bag from the upper ends until the middle seam opens

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• Roll up the bag from the upper edge, until the Lambda seam of the lower triangle is completely opened

• Hang the PD fluid bag together with its drainage bag on the infusion pole

• Do not unroll the tubing

• To safely connect the bag connector to the DISC place the DISC in an organizer

• Place the bag connector into the organizer: – On the right-hand side if you are right-handed – On the left-hand side if you are left-handed

• Disinfect your hands/change gloves and put on face mask for bag connection – according to your hospital procedure

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Headline Recommended handling procedures PD-Paed Plus Sub-Headline

• Unscrew the protection cap of the DISC and discard it

• Unscrew the protection cap from the system’s bag connector and screw the bag connector onto the DISC

• Repeat these steps to connect the second bag, if required

6. Priming the system

• Turn the control switch of the DISC clockwise to the last of the 3 dots •◐•

• Leave the control switch in this position

• Arrange the position of the burettes in the holders so that the measurement gradients you want to use are visible:

• Inflow burette: left measurement gradient for exchange volumes >10 ml; right measurement gradient for inflow by drops

• Outflow burette: right measurement gradient is recommended

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• To prime the line open the blue clamp between the DISC and the inflow burette; fill the inflow burette to min. 150 ml. Then close this blue clamp.

• Fill the drip chamber completely by squeezing it. (The drip chamber contains exactly 10 ml if fully filled)

• Ensure that the ball of the safety valve is floating Note: • If you want to perform inflow by drops do not fill the drip chamber completely

• Open blue clamp near the Y-piece to prime the patient connector completely

• Clamp the patient connector with a scissor clamp • Place the patient connector back into the lower organizer

• Open the yellow clamp after the Y-piece to prime the whole system and to check the functionality of the safety valve by emptying the inflow burette and the drip chamber with the safety valve completely Make sure that the roller clamp is open. Make sure the scissor clamp is still closed to avoid air in the outflow system. The ball closes the safety valve as soon as the drip chamber is empty

• Close the blue and yellow clamp near the Y-piece • Remove the scissor clamp • To empty the outflow burette open the yellow clamp on the drain line. Drain the burette completely. Then close the clamp

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Headline Recommended handling procedures PD-Paed Plus Sub-Headline

• Fill the inflow burette to prescribed inflow volume for the first cycle

• In case a warming appliance is used, make sure that it is properly assembled onto the infusion pole and that the PD-Paed Plus is properly inserted (For the operation of the warming appliance please refer to the manufacturer’s instructions for use)

7. Connecting the patient

• Close the clamp on the catheter extension for the connection • Place the catheter extension into the organizer – On the right-hand side if you are right-handed – On the left-hand side if you are left-handed

• Disinfect your hands/change gloves and put on face mask, if required by your hospital procedure

• Unscrew the protection cap of the patient connector and discard it

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• Unscrew the catheter extension from the disinfection cap and screw onto the patient connector

• Open the clamp on the catheter extension • Remove the patient connector from the organizer, if needed • Ready to start the treatment!

8. Outflow

• Open the yellow clamp between the patient connector • • • • •

and outflow burette Observe the fluid for clarity and fibrin When drain is completed close this yellow clamp Measure and record the amount of dialysate drained To empty the outflow burette, open the yellow clamp between the outflow burette and the drainage bag Close this yellow clamp when drain is completed

Note: • If you are using a warming appliance refer to the user’s manual for the recommended pre-warming time of the PD fluid • Storing the PD fluid at room temperature (22°C) will reduce pre-warming time • If you are using the recommended warming appliance Barkey Warming System XPT for PD-Paed Plus, discard 15 – 20 ml of PD fluid before each inflow by adding the discarded amount into the inflow burette • If you are not using the recommended warming appliance Barkey Warming System XPT for PD-Paed Plus, flush the system before each inflow with prewarmed PD fluid by adding the flush amount into the inflow burette

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Headline Recommended handling procedures PD-Paed Plus Sub-Headline

9. Inflow To avoid the risk of overfilling always make sure that the outflow is completed. It is strongly recommended that PD fluid is warmed to body temperature before infusion into the child! 1 • Fill the inflow burette: open the blue clamp between the DISC and the inflow burette and fill to the prescribed volume; then close this clamp Open the blue clamp on the inflow line to infuse the PD fluid. • Use the roller clamp to adjust inflow speed • Closely observe the level in the burette during inflow! • Close the blue clamp when the prescribed volume has been infused 1 “Pediatric Nephrology”, Ellis D. Avner et al., 5. edition, p. 1381

10. Dwell

• Dwell time according to the physician’s orders • Refill the inflow burette with prescribed PD fluid for the next cycle and use the dwell time to pre-warm the PD fluid appropriately Repeat the above procedure steps 8 – 10 for next cycle

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11. Disconnecting the patient

• Remove the patient connector from the organizer if it was placed there.

• Turn the blue button on the patient connector clockwise

• Then firmly push the blue button all the way into the patient connector. The PIN will be released and introduced into the catheter extension automatically

• Open outer wrapper of the disinfection cap and leave it in the packaging

• Put on face mask and disinfect your hands/put on gloves – according to your hospital procedure

• Close the clamp on the catheter extension • Place the patient connector into the CLIP of the organizer

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Headline Recommended handling procedures PD-Paed Plus Sub-Headline

• Insert the disinfection cap into the left-hand side of the organizer (right-hand side if you are left-handed)

• Unscrew the protection cap from the new disinfection cap and discard

• Unscrew the catheter extension from the patient connector

• Screw the catheter extension which now has the PIN inside securely onto the new disinfection cap and pull the catheter extension from the organizer (the PIN is visible through the transparent cap)

• Remove face mask, if applicable

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12. Option: Pause the treatment a) Disconnecting with PIN Reload device

• Use the PIN Reload device to disconnect the patient from the PD-Paed Plus during the dwell phase of the treatment. Before preparing to disconnect from the PD-Paed Plus have the following ready: – Disinfection cap – PIN Reload device – Face mask (according to your hospital procedure) – Hand disinfectant/gloves (according to your hospital procedure)

• Turn the blue button on the patient connector clockwise. Firmly push the blue button all the way into the patient connector. Close the clamp on the catheter extension

• Place the patient connector into the organizer • Place a new disinfection cap into the left-hand side of the organizer (right-hand side if you are left-handed)

• Place a PIN Reload device into the right hand side of the organizer (left-hand side if you are left-handed)

• Use a face mask for the next steps, if required by hospital procedure

• Disinfect your hands/put on gloves – according to your hospital procedure

• Unscrew the protection cap from the new disinfection cap • Unscrew the catheter extension from the patient connector of the set. Screw the catheter extension with PIN securely onto the new disinfection cap

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Headline Recommended handling procedures PD-Paed Plus Sub-Headline

• Unscrew PIN Reload device and screw on the patient connector

• Remove catheter extension from the organizer

b) Reconnecting to PD-Paed Plus

• Ensure that the patient connector is still secured in the organizer and the PIN Reload device is still screwed to the patient connector. Remove the catheter extension from where it was secured on the patient.

• Place the catheter extension into the right-hand side of the organizer (left-hand side if you are left-handed)

• Use a face mask for the next steps, if required by hospital procedure

• Disinfect your hands/put on gloves – according to your hospital procedure

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